Bruxism protective device

ABSTRACT

A one-piece molded bruxism treatment device which in upright orientation has top and bottom parts, including: an elongated band having a generally U-shape defining a closed front end part and legs extending rearward and adapted to be positioned around the outer surfaces of a person&#39;s upper gums and teeth, and two generally planar resiliently deformable bite pads oriented generally horizontally, each extending from one of the feet of the band medially toward the other.

Related cases: This application is a divisional of U.S. patentapplication Ser. No. 12/316,922 filed Dec. 16, 2008, now U.S. Pat. No.8,196,587, and claims the benefit of U.S. Provisional Patent ApplicationNo. 61/281,441 filed Nov. 16, 2009, which is hereby incorporated byreference herein.

I. FIELD OF THE INVENTION

This invention relates to devices and methods for treatment of bruxismand stress-related temporomandibular dysfunction. More specifically,this invention relates to an intraoral device adapted to be positionedbetween a person's upper and lower teeth to prevent grinding of theteeth and to reduce forces applied to the teeth, gums and jaw bones fromgrinding of the teeth while a person sleeps.

II. BACKGROUND AND PRIOR ART

Bruxism is the term that refers to a grinding and clenching of theteeth, unintentionally, and at inappropriate times. Bruxers (personswith bruxism) are often unaware that they have developed this habit, andoften do not know that treatment is available until damage to the mouthand teeth has been done; however, each individual may experiencedifferently bruxism symptoms which may include: abraded teeth, facialpain, oversensitive teeth, tense facial and jaw muscles, headaches,dislocation of the jaw, damage to the tooth enamel, exposing the insideof the tooth (dentin), a popping or clicking in the temporomandibularjoint (TMJ), tongue indentations, and/or damage to the inside of thecheek.

While the causes of bruxism are sometimes not known or not recognizedbecause they may resemble other conditions or medical problems, oralhealth specialists often point to excessive stress and certainpersonality types as typical causes of bruxism. Bruxism often affectspersons with nervous tension such as anger, pain, or frustration, and/orpersons with aggressive, hurried, or overly competitive tendencies.

Bruxism may be diagnosed during regular visits to the dentist where theteeth are examined for evidence of bruxism—often indicated by the tipsof the teeth appearing flat. If symptoms are present, the condition willbe observed for changes over the next several visits before a treatmentprogram is established.

Specific treatment for bruxism will be determined by one's dentist orphysician based on the person's: age, overall health, and medicalhistory; extent of the disease; tolerance for specific medications,procedures, or therapies; expectations for the course of the disease;and/or opinion or preference.

In many cases bruxism can be successfully treated by:

a. behavior modification by teaching the patient how to rest his/hertongue, teeth, and lips properly, and learning how to rest the tongueupward may relieve discomfort on the jaw while keeping the teeth apartand lips closed,

b. a specially-fitted plastic mouth appliance may be worn at night toabsorb the force of biting. This appliance may help to prevent futuredamage to the teeth and aid in changing the patient's behavior, and

c. biofeedback which involves an electronic instrument that measures theamount of muscle activity of the mouth and jaw—indicating to the patientwhen too much muscle activity is taking place so that the behavior canbe changed. This is especially helpful for daytime bruxers. Bruxismpatients may present with a variety of symptoms, including anxiety,stress, tension, depression, earache, eating disorders, insomnia,headache and/or jaw pain. Eventually, bruxing shortens and blunts theteeth being ground, and may lead to myofacial muscle pain,temporomandibular joint dysfunction and headaches. In severe, chroniccases, it can lead to arthritis of the temporomandibular joints. The jawclenching that often accompanies bruxism can be an unconsciousneuromuscular daytime activity, which should be treated as well, usuallythrough physical therapy (recognition and stress response reduction).

Prior art bruxism management techniques include minimizing the abrasionof tooth surfaces by the wearing of an acrylic dental guard or splint,designed to the shape of an individual's upper or lower teeth from abite mold. Mouth guards are obtained through visits to a dentist formeasuring, fitting, and ongoing supervision. There are four possiblegoals of this treatment: constraint of the bruxing pattern such thatserious damage to the temperomandibular joints is prevented,stabilization of the occlusion by minimizing the gradual changes to thepositions of the teeth that typically occur with bruxism, prevention oftooth damage, and the enabling of a bruxism practitioner to judge inbroad terms the extent and patterns of bruxism, through examination ofthe physical indentations on the surface of the splint. Dental guardstypically worn on a long-term basis during every night's sleep, may beseen in U.S. Pat. Nos. 4,976,618, 5,873,365, and 6,152,138. Another typeof device sometimes given to a bruxer is a repositioning splint whichmay look similar to a traditional night guard, but is designed to changethe occlusion or “bite” of the patient.

Bruxism is associated with a person's mandible which is connected to thecranium by the temporomandibular joints located immediately in front ofthe ears. Rotation of the mandible about these joints is accomplished bythe masticatory muscles, each of which extends from an opposite side ofthe mandible to a connecting point on the cranial bones. The masticatorymuscles have an at rest position between their extended and contractedstates. Under normal physiological conditions involving the outgrowth ofa full complement of teeth, the mandibular portion of eachtemporomandibular joint will rest lightly in the cranial portion of thejoint, and the muscles will be relaxed or at rest.

Masticatory muscle related stresses and/or pain can arise due todifferences in occlusal pressures along the upper and lower dentalarches. Temporomandibular joint dysfunction syndrome relates toocclusion-muscle incompatibility. Masticatory muscle accommodation is akey factor in the etiology of this syndrome. Psychological tension andstress can lead to temporomandibular joint dysfunction or bruxism inotherwise stable mouths with normal occlusion.

The most frequent jaw movement involves elevation of the mandible fromits rest position into centric occlusion. Simple elevation of themandible is normally powered almost entirely by the elevator muscles,other muscles providing only a minor bracing action. The bilateraltemporals, masseters and medial pterygoids provide an excess supply ofelevator motor units. Since these motor units alternate in function,with fatigued units “dropping out” to rest while others take theirplace, mandible elevation can be continued almost indefinitely withoutover fatiguing these muscles.

Occlusion-muscle dysfunction alters this condition drastically becauseaccommodation has a highly selective effect on the masticatory muscles,increasing their activity disproportionately in certain areas of thebilateral complex. In the presence of occlusion muscle disharmony, atraumatic closure into centric occlusion requires that the mandible beadjusted every time it is elevated into occlusion. If, for example, therequired adjustment is horizontal, the muscle areas capable of producingsuch horizontal movements must be called into activity with the samefrequency as are the elevator muscle areas. Unfortunately, there are farfewer of these horizontal-adjustor motor units than elevator motorunits.

Ultimately the functional capacity of these comparatively few horizontalmotor units is exceeded, which triggers an exhaustion-incoordination-spasm sequence and development of the temporomandibularjoint syndrome symptoms. The resulting tenderness and spasms are foundmost frequently in the lateral pterygoid muscles which function asanterior adjustors of mandibular placement.

In psychological stress related syndromes the muscles become fatigued asa result of nocturnal clenching or grinding of the teeth. Thesenocturnal activities give rise to the same symptoms asmalocclusion-based temporomandibular joint dysfunction.

The sequence of muscle dysfunction spreads beyond the masticatorymuscles, producing an entire constellation of primary symptoms of thetemporomandibular joint pain-dysfunction syndrome. These symptomsinclude pain and/or tenderness in the temporomandibular joint area ormasticatory muscles; “clicking” in the temporomandibular joint;limitation of jaw opening; restriction of jaw movement; and secondarysymptoms which are medical in nature, being transmitted to other, moredistant areas of the head and neck. These secondary symptoms probablyinclude some of the most widespread and problematic conditions medicinehas to deal with, namely, headache (including “tension” headaches),atypical facial neuralgias, tinnitus and neck and ear pain, amongothers. Also, certain neuromuscular disorders of the face, head andneck, shoulders, back, arms and hands can occur. These secondarysymptoms are functional disturbances which exhibit no organic changes inthe affected tissues, making diagnosis difficult. They are oftenill-defined and difficult for the patient to describe.

These symptoms are usually diagnosed as purely medical in nature becausethey occur at some distance from the teeth. Their masticatory muscleorigin unfortunately is not readily apparent. The usual result is thattreatment is mistakenly directed to the secondary symptom's localerather than to the underlying “invisible malocclusion.” Such invisiblemalocclusions are common but difficult to detect. Intercuspation of theteeth appears normal, while the underlying faulty(accommodation-necessitating) craniomandibular relationship is hidden bythe automatic compensatory action of the muscles. The secondary symptomsresulting from temporomandibular joint dysfunction thus are usuallytreated palliatively instead of having their basic cause eliminated. Formalocclusion-based muscle dysfunction definitive therapy is essentiallyan orthopedic procedure and requires correction of the faultycranio-mandibular relationship by a dentist. For psychologicalstress-related dysfunctions treatment may be addressed in other ways.

Some notable prior art methods of treating temporomandibular jointdysfunction and bruxism include clinical monitoring devices to measurethe amount of pressure being asserted, splints to be worn during sleepto prevent the wearing of teeth, and behavior modification deviceswherein an electrical shock is provided to the jaw muscles to interrupta nocturnal episode without waking the patient.

The present invention provides a new intraoral device to be used when aperson sleeps, this device being positioned between the person's upperand lower teeth to reduce symptoms and damage caused by bruxism andtemporormandibular dysfunction. It is effective, very simple to use andrelatively low in cost.

III. OBJECTS AND SUMMARY OF THE NEW INVENTION

The present invention addresses the problem of “grinding” during sleepwhere grinding may have the form of clenching generally axially betweenupper and lower teeth, or axial combined with side-to-side grinding oraxial combined with front-to-rear grinding or combinations of same. Thisinvention provides a novel intraoral device which is generallyhorseshoe-shaped, and in its preferred embodiment designed to have itstwo bite pads received between the upper and lower teeth on the left andright sides of the person's mouth. An elongated band has its oppositeends connected to the two bite pads respectively, and a central portionthat extends from the bite pads as a U-shaped arch forward and aroundthe front of the upper gums and upper teeth or around the lower gums andlower teeth.

The new device, as applied to the upper teeth, has at the top edge ofthe band at the front, a downward extending notch or recess to allowspace for the upper frenulum, so that the band can avoid engaging andirritating the frenulum. This device can be inverted and employed withthe band extending from the bite pads forward and around the lower gumsand lower teeth and adjacent the lower frenulum. Whether the band issituated adjacent the upper or lower gums and teeth, the bite pads arepositioned between upper and lower rear teeth and the notch at the frontof the band accommodates the upper or lower frenulum respectively.

The bite pads are generally flat plates of a soft and resilientlydeformable material to absorb forces applied by the upper and lowerteeth to each other when grinding would occur. To achieve resilientdeformability many variations of structure of the pads are possible, asdescribed below.

The top surfaces may have upward extending projections in the form ofribs or bumps which may extend in longitudinal, parallel, transverse,diagonal, circular, random or other patterns.

Alternatively, the bottom surface of each pad may have similarprojections as described above for the top surface, or top and bottomsurfaces may both have such projections. Instead of ribs or bumps theremay be grooves or dimples. In all these non-limiting examples, thesurface allows for deformation, bending, and/or compression, so that thepad material can absorb forces applied to the teeth against each otherthat would otherwise cause grinding of teeth surfaces while a personsleeps.

In still additional structural forms the pads include holes or otherapertures transverse of the pad surface to allow resilient flow and/ormovement the plastic or rubber material forming the pad. Resilience is arequirement, since biting down and grinding will occur intermittentlyand repeatedly, and the device must be able to respond with sufficientstrength and resilience each time forces are applied.

The device described above has the forward extending strap adapted tolie as a horseshoe shape adjacent the arch of upper teeth. As notedabove, this device can be inverted for the strap to lie adjacent thearch of the lower teeth. In the former style of device there is a recessor notch extending downward to accommodate the frenulum adjacent theupper lip, and in the latter version style there is a notch extendingupward to accommodate the frenulum adjacent the lower lip.

In a still further variation of the version for lower teeth with thestrap lying adjacent the lower teeth, has an additional bite pad nearthe front and center of the strap to extend as a hook rearward over andbehind the top edge of the front center teeth. This center pad thenserves as an anchoring element to more securely keep the device's bitepads at the ends of the strap from moving forward or rearward duringuse. These bite pads are already restrained from moving rearward by thefact that the strap sits adjacent the front surface of the front teeth;however, this latter embodiment with a front hook element will alsoprevent any small or large movement in the forward direction.

The bite pads described herein are energy absorbing, having a degree ofresilient resistance to deformation that occurs with compression,bending and/or stretching of the material or of layers or elements ofthe material of the pads. As described herein, such deformation isallowed by the shape of the surface or by the composition of the padsthemselves. For example, a pad may have, in section, a wave shape thatrises and falls on both top and bottom surfaces or on one surface only.A still additional possibility is to have air pockets inward of the topand bottom surfaces. This would provide resilient resistance anddeformation.

The new bruxism device is preferably a one-piece molded plastic articlewhere the bite pads are relatively soft and resilient to repeatedlyresist and cushion the grinding and clenching forces yet strong enoughto not permit the upper and lower teeth to bite through the pads orotherwise damage or destroy them. Because of manufacture by high speedmulti-cavity molds, the costs can be greatly reduced allowing the retailsale price to be so low that it is now feasible for this to be adisposable product after each one-night use. From this flow numerousadvantages, including the elimination of the tasks of cleaning,disinfecting, storing and finding a reusable bruxism bite pad of theprior art, and avoid the high initial cost of such devices.

Still further advantages in use of the new device include the ease,comfort, safety and successful results. This device achieves its goalswith a minimal size structure in the mouth that can become hardlynoticeable as compared to far larger prior art devices. Also, this samedevice has the benefit of being usable upright on the lower teeth orinverted on the upper teeth, whichever is more comfortable.

A still further advantage of this new device is its essentially almostuniversal fit for many sizes and shapes of human mouths. The simpledesign, thin flexible band and relatively small bite pads allow a singledevice to conform easily to many different mouths. This further allowsmass production at a lower cost because different many different sizesare not required, and reduces the burden on patients to find aparticular size.

It is therefore an object of this invention to provide an effective andeasy-to-use therapeutic apparatus for use in treating temporomandibularjoint dysfunction and bruxism.

It is a further object of this invention to provide a therapeuticapparatus and method which is inexpensive to manufacture.

It is another object of this invention to provide a therapeuticapparatus which does not have to be used with direct and frequentclinical supervision.

It is also an object of this invention to provide a dental appliancewhich can be used “directly out-of-the-package” and will fit a greatnumber of different persons, and thus does not have to be cut, boiled,molded or cast for each individual patient.

An additional object is to provide a bruxism protective device that isreversible and can be used with the band adjacent either to the upper orlower gums and teeth.

An exemplary first embodiment of the present invention is a one-piecemolded bruxism treatment device which in upright orientation has top andbottom parts, comprising:

a. an elongated band having top and bottom edges and having a generallyU-shape defining a closed front end part and legs extending rearwardalong a front-to-rear direction, and adapted to be positioned around theouter surfaces of a person's upper gums and teeth, said front end andlegs having top and bottom edges, each of said legs terminating as afoot having a bottom edge below the bottom edges of said front end andlegs,

b. said front end top edge having a downward extending recess adapted toprovide clearance for a person's frenulum when said device is positionedin the person's mouth with said band between said person's upper lip andupper teeth, and

c. two generally planar bite pads oriented generally horizontally, eachextending from one of said feet of said band medially toward the other,each of said bite pads having top and bottom surfaces and adapted to bepositioned on one side of the person's jaw between the facing surfacesof a person's upper and lower teeth, and

d. each said bite pads being, at least in part, resiliently deformable,thus adapted to absorb forces when said bite pad is clenched between theperson's upper and lower teeth.

Another embodiment includes the additional structural feature whereineach of said pads has a medially outer edge where it extends from one ofsaid feet and an opposite medially inner edge spaced from and generallyparallel to said medially outer edge and a top surface, each of saidpads further comprising a stabilizing rib along said medially inner edgeand extending selectively, upward, downward or upward and downward fromsaid top surface of said pad, each of said stabilizing ribs adapted tobe situated medially inward of the inward sides of said upper and lowerteeth when they clench said bite pad.

In another embodiment said band further comprises a hook elementextending contiguously from said band at its closed end toward said openend and then curving upward, thus adapted to extend around the exposededge and behind the rear surface of at least one of the user's frontteeth, and thus to stabilize said device from moving forward or rearwardrelative to said front teeth

A still further embodiment is specifically defined as being a disposabledevice, which is intended to be discarded after a single use.

These and other advantages of the invention will be further understoodand appreciated by those skilled in the art by reference to thefollowing written specification, claims and appended drawings.

IV. BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top rear perspective view of a first embodiment of a newbruxism bite pad device for application to a lower jaw and teeth,

FIG. 2 is a top left side perspective view of the bruxism bite pad ofFIG. 1 as applied to a lower jaw and teeth,

FIG. 3 is a left side elevation view of the bruxism bite pad of FIG. 2,

FIG. 4 is a top rear perspective view of a second embodiment of the newbruxism bite pad device for application to a lower jaw and teeth butwith a front hook element,

FIG. 5 is a rear perspective view of the bite pad similar to the bitepad of FIG. 4 as applied to a lower jaw and teeth,

FIG. 6 left side elevation view of the bite pad of FIG. 5.

FIG. 7 is an enlarged fragmentary perspective view of a furtherembodiment of the hook portion of the bite pad of FIG. 4,

FIGS. 8-18 are fragmentary top perspective views of eleven alternateforms of the pad portions that may be used with the bruxism devices ofFIGS. 1 and 4,

FIG. 19 is a top rear perspective view of a third embodiment of abruxism bite pad device for application to a lower jaw and teeth,

FIG. 20 is a sectional elevation view taken along line 20-20 in FIG. 19,

FIG. 21 is a top rear perspective view of a fourth embodiment of the newbite pad for application to an upper jaw and teeth,

FIG. 22 is a bottom rear perspective view thereof,

FIG. 23 is a top front perspective view of a further embodiment of thenew device,

FIG. 24 is a top rear perspective view thereof,

FIG. 25 is a bottom front perspective view thereof, and

FIG. 25 is a perspective view of a further embodiment having three bitepads.

The features of the invention will become apparent from the followingdescription of the exemplary embodiments taken in conjunction with theaccompanying drawings.

V. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

For convenience and clarity in describing these embodiments, similarelements or components appearing in different figures will have the samereference numbers.

FIGS. 1-3 illustrate a first embodiment of the new bruxism protectivedevice 10 which includes an elongated band portion 12 of general U-shapehaving a closed end and legs 13 extending rearward along a front-to-reardirection, each of said legs terminating as a foot 13A having a top edge13B above the top edge 13T of said front end and leg 13, and a bite pad14 extending medially from one of said feet 13A. This is a one-piecemolded device of a flexible and resilient plastic such as athermoplastic elastomer, for example DuPont's Elvaloy™, PVC, siliconesand other plastics. The required softness-toughness and resilientcushion characteristics may be achieved, for example, with material ofDurometer index 00-A on the Shore scale. In a still further variationthe above-mentioned material characteristics may be achieved by alaminate having a soft surface and a tougher inner layer.

Band 12 is curved to generally match the curvature of a person's jaw;however, the band is sufficiently pliable to fit exactly to differentsize jaws or even to lie flat in a package. At the lower edge of band 12at the center front area is an upward extending recess 16 adapted to bepositioned adjacent but without contacting or rubbing against the user'slower lip frenulum. This device may be inverted as seen in FIGS. 21-25for use with a person's upper jaw, with recess 16 then adjacent theuser's upper frenulum.

FIGS. 2 and 3 illustrate the device 10 of FIG. 1 as applied to aperson's lower jaw 16 and teeth 17. As seen, the front portion 12A band12 is situated around the front area of the gums and teeth, and theremainder of the band extends around and adjacent the sides of the jaw,until bite pads 14 are placed on top of lower teeth 17 on the left andright sides respectively. When the plane of band 12 is generallyvertical bite pads 14 are in a generally horizontal plane at anelevation above the top edge 12T of the band, so they can extend fromthe outside and then over the top surfaces of teeth 17. As representedschematically in FIG. 3, recess 16 at the front of band 12 fits over andabove and without interfering with the lower lip frenulum 20 which issituated between the lower lip 21 and the lower gum.

FIGS. 4-6 illustrate a second embodiment 30 of the new bruxismprotective device which differs from the first embodiment 10 in FIGS.1-3 by the addition of a hook element 32 at the top front area of band12 and directly above the recess 16. As shown in FIGS. 5 and 6, hookelement 32, is situated to lie over the top of the lower front teeth 34and have its rear tab portion 35 extend downward behind said frontteeth.

Bruxism device 30 is used generally the same as device 10 in FIGS. 1-3,except that with a hook element 32, device 30 is precluded from slidingforward, which might occur when the upper and lower jaws and teeth areseparated and no pressure is applied to bite pads 14. Hook element 32 isan added stabilization feature, which is not required in the simplerdesign of device 10. Hook element 32 can furthermore serve as anauxiliary bite pad between upper and lower front teeth.

FIG. 7 illustrates a variation 36 of the above-mentioned hook element,this variation extending rearward and downward as tab 37 with laterallyextending left and right ears 38 and 39 for enhanced engagement andstability with the lower front teeth.

FIGS. 8-18 illustrate a variety of alternate forms of bite pads whichwill be described in detail as follows. In FIG. 8 bite pad 40 has a wavyor waffle construction of laterally extending ribs 41 forming hills 42and valleys 43. FIG. 9 shows bite pad 44 which is essentially flat alongthe top and bottom surfaces, generally as appears in FIGS. 1 and 4.

FIG. 10 shows a bite pad 48 which has a plurality of round holes 49extending vertically through the pad between its top and bottomsurfaces. FIG. 11 shows bite pad 50 with longitudinally extending ribs51 defining hills 52 and valleys 53, these wavy ribs extendinglongitudinally as compared with ribs 41 in FIG. 8 which extend laterallyor transversely. In FIG. 12 bite pad 54 has diagonally intersectinggrooves 56 which extend downward into the top surface of the bite pad.In FIG. 13 the bite pad 60 has parallel grooves 62 extending diagonally.In FIG. 14 bite pad 64 has wavy grooves 66 extending laterally. In FIG.15 bite pad 68 has diagonal ribs 70 which extend upward from the topsurface of the bite pad. In FIG. 16 bite pad 72 has upward extendinggenerally around or oval bumps 74. In FIG. 17 bite pad 76 has closelyspaced small ribs 78 extending transversely. In FIG. 18 bite pad 80 hasa plurality of closely spaced small ribs 82 extending longitudinally.

FIGS. 19 and 20 illustrate a still further embodiment of the bite pad90, which has an upward extending longitudinal stabilizing rib 91 at theinward or medial edge 92 of bite pad 90. FIG. 20 shows also in dashedline an optional alternative downward extending stabilizing rib 91A, anda further alternative would be to include both upward and downwardstabilizing ribs 91 and 91A. As seen in FIGS. 19 and 20, in use of bitepad 90, its stabilizing rib 91 is situated slightly inward of the lowerinward edge 93 of the upper tooth 94. So long as the upper tooth 94 andimmediately adjacent lower tooth 95 are closed down on bite pad 90,stabilizing rib 91 will prevent bite pad 90 from sliding laterally inthe direction of the arrow 95 and outward from between said upper andlower teeth.

In regard to all of the bite pads, the objective is to have acompressible material which can resist compressive forces between upperand lower teeth in a cushioning manner with a predetermined amount ofresistance and return to its normal state after compression. Compressionis allowed because of the characteristics of the plastic or rubbermaterial from which the bite pad is made, and/or from the geometry orengineered structure that has been illustrated in the numerousembodiments of FIGS. 7-17. Deflection and/or deformation can occur notonly from inherent compressibility of the bite pad material, but alsowhen ribs are pushed into adjacent grooves, or when hills are pressedinto adjacent valleys, or bumps are squashed down, or projections arebent, or any bite pad material is deformed and pushed into adjacentdepressions or apertures, providing relief space for resilient plasticflow of the bite pad material.

Thus, bite pads can resiliently deflect, compress, bend or otherwisedeform by compressing or flattening of “hills” of the bite pad of FIGS.8 and 11, by flowing of bite pad material into aperture areas in pads ofFIG. 10, by bending, compressing or flowing rib material into adjacentgroove areas in pads of FIGS. 11-15 and 17-18, or by compressingprojections in pads of FIG. 16.

FIGS. 21 and 22 illustrate a still further embodiment 100 of the newbruxism protective device, this embodiment being essentially the same asdevice 10 in FIG. 1, but inverted and used with band 111 adjacent to theupper teeth and upper jaw, and bite pads 112 still situated between setsof upper and lower rear teeth. With device 100, its recess 16 extendsupward instead of downward to be clear of the upper frenulum. In thisparticular device 100, bite pads 112 have in their upper surfaceslongitudinal spaced apart grooves 113.

FIGS. 23-25 show a still further embodiment 115 with a modified frontbite plate-hook part 116 and modified bite plates 118, the entirestructure having more smooth transition areas between component partswhich is beneficial for manufacture, appearance and ultimate use. Inthis embodiment, as with the embodiments of FIGS. 1, 4 and 21, the bitepads are a continuous extension of the band at an elevation and in aplane above the top edge of the band.

FIG. 26 shows a still further embodiment 120 of the new bruxismprotective device having left and right bite pads 121, 122 and frontbite pad 123. In this embodiment all three bite pads are at the sameelevation; however, the elevation and width of the front bite pad mayvary.

While the invention has been described in conjunction with severalembodiments, it is to be understood that many alternatives,modifications, and variations will be apparent to those skilled in theart in light of the foregoing description. Accordingly, this inventionis intended to embrace all such alternatives, modifications, andvariations which fall within the spirit and scope of the appendedclaims.

The invention claimed is:
 1. A one-piece molded bruxism treatment devicewhich in upright orientation has top and bottom parts, comprising: a. anelongated flexible band having top and bottom edges and having agenerally U-shape defining a closed front end part and legs extendingrearward along a front-to-rear direction, and adapted to be positionedaround the outer surfaces of a person's upper gums and teeth, said frontend and legs having top and bottom edges, each of said legs terminatingas a foot having a bottom edge below the bottom edges of said front endand legs, b. said front end top edge having a downward extending recessadapted to provide clearance for a person's frenulum when said device ispositioned in the person's mouth with said band between said person'supper lip and upper teeth, and c. two generally planar bite padsoriented generally horizontally, each molded with the band to extendcontiguously from one of said feet of said band medially toward theother, each of said bite pads having top and bottom surfaces and adaptedto be positioned on one side of the person's jaw between the facingsurfaces of a person's upper and lower teeth, and d. each said bite padsbeing, at least in part, resiliently deformable, thus adapted to absorbforces when said bite pad is clenched between the person's upper andlower teeth, wherein each of said pads has a medially outer edge whereit extends form one of said feet and an opposite medially inner edgespaced from and generally parallel to said medially outer edge and a topsurface, each of said pads further comprising a stabilizing rib alongsaid medially inner edge and extending selectively, upward, downward orupward and downward from said pad, each of said stabilizing ribs whensaid device is positioned in said person's mouth, adapted to be situatedmedially inward of the inward sides of said person's upper and lowerteeth when they clench said bite pad.
 2. The bruxism treatment deviceaccording to claim 1, wherein said bite pads extend in a generallycommon plane from said opposite feet respectively of said band at saidelevation below the bottom edges of said front end and legs.
 3. Thebruxism treatment device according to claim 1 wherein each of said padsis resiliently compressible when clinched between the person's upper andlower teeth.
 4. The bruxism treatment device according to claim 1wherein each of said pads includes a plurality of apertures extendingthrough the pad between its top and bottom surfaces and spaced apartlaterally from each other, each pad when clenched by teeth, thus adaptedto deform with material of the pad adjacent said apertures resilientlyflowing into areas of said apertures.
 5. The bruxism treatment deviceaccording to claim 4 wherein material of said pad is adapted to migratetoward said apertures when force is applied to said top and bottomsurfaces of said pad adjacent said apertures, whereby said pad absorbssome of the compression forces applied thereto when a pad is clenchedbetween a user's teeth.
 6. The bruxism treatment device according toclaim 1 wherein at least one of said top and bottom surfaces of each ofsaid pads has a plurality of resiliently deformable projectionsextending from said surface.
 7. The bruxism treatment device accordingto claim 6 wherein said projections extend from both of said top andbottom surfaces.
 8. The bruxism treatment device according to claim 6wherein said projections define a pattern of spaced apart ribs.
 9. Thebruxism treatment device according to claim 8 wherein said ribs aregenerally parallel and oriented in a said front-to-rear direction. 10.The bruxism treatment device according to claim 8 wherein said ribsextend generally transversely of said front-to-rear direction.
 11. Thebruxism treatment device according to claim 8 wherein said ribs defineconcentric circles.
 12. The bruxism treatment according to claim 6wherein said projections are resiliently bendable.
 13. The bruxismtreatment device according to claim 1 wherein each of said pads includeson at least one of its top and bottom surface a pattern of dimples. 14.The bruxism treatment device according to claim 1 wherein said at leastone of said top and bottom surfaces of each of said pad has a pluralityof spaced apart grooves extending inward from said surface.
 15. Thebruxism treatment device according to claim 14 wherein said grooves aregenerally parallel and oriented generally transverse of saidfront-to-rear direction.
 16. The bruxism treatment device according toclaim 1 wherein each of said pads defines spaced-apart ribs extendingtransversely of said front-to-rear direction, where each of said pads invertical cross-section defines a wave pattern.
 17. The bruxism treatmentdevice according to claim 1 wherein each of said pads has a mediallyouter edge where it extends from one of said feet and an oppositemedially inner edge spaced from and generally parallel to said mediallyouter edge and a top surface, each of said pads further comprising astabilizing rib along said medially inner edge and extendingselectively, upward, downward or upward and downward from said pad, eachof said stabilizing ribs when said device is positioned in said person'smouth, adapted to be situated medially inward of the inward sides ofsaid person's upper and lower teeth when they clench said bite pad. 18.The bruxism treatment device according to claim 1 formed of plastichaving compressibility defined by a Shore A/D hardness 78/27.
 19. Thebruxism protective device according to claim 1 wherein said band hasthickness of about 2 mm and said bite pads have thickness of about 2 mm.20. A disposable one-piece molded bruxism treatment device comprising:a. an elongated flexible band having top and bottom edges and having agenerally U-shape defining a closed front end and legs extendingrearward along a front-to-rear direction, and adapted to be positionedaround the outer surfaces of a person's upper gums and teeth, said frontend and legs having top and bottom edges, each of said legs terminatingas a foot having a bottom edge below the bottom edges of said front endand legs, b. two generally planar bite pads oriented generallyhorizontally, each molded with the band to extend from one of saidopposite ends of said band medially toward the other, each of said bitepads having top and bottom surfaces and adapted to be positioned on oneside of the person's jaw between the facing surfaces of a person's upperand lower teeth, c. said band further comprising a hook elementextending contiguously from said band at its closed end toward said openend and then curving upward, thus adapted to extend around the exposededge and behind the rear surface of at least one of the user's frontteeth and thus stabilize said device from moving forward or rearwardrelative to said front teeth, d. each said bite pads being resilientlydeformable, thus adapted to absorb forces when said bite pad is clenchedbetween the person's upper and lower teeth, and e. a stabilizing railextending selectively upward, downward or upward and downward from atthe inner medial edge of each of said bite pads, and extending in saidfront-to-rear direction of said bite pad, each of said rails adapted tobe situated medially inward of the inward sides of said teeth.